KR20200140935A - Therapeutic eye treatment with gases - Google Patents

Abstract

The device 100 for maintaining the environment over the anterior surface of a patient's eye includes a sheath 110, the sheath having a size and shape that sits around the patient's eye to form a cavity 112 within the sheath. The enclosure may be configured to contain a fluid other than ambient air in contact with the patient's eye. The device may include a fluid regulator 1209 in communication with the sheath, and the fluid regulator may be configured to regulate the composition of the fluid contained within the sheath.

Description

Eye treatment method using gas {THERAPEUTIC EYE TREATMENT WITH GASES}

Priority claim

This application has priority to US Provisional Patent Application No. 62/305,751 entitled "Therapeutic Eye Treatment Method Using Gas" by John Berdahl, filed March 9, 2016, and incorporated herein by reference in its entirety. Claim profit

Patient compliance in applying therapeutic substances to the eye is important in treating eye diseases such as glaucoma. Topical dosing, such as eye drops, can drain quickly from the eye thereby minimizing contact time with absorbent surfaces such as the cornea, sclera, and conjunctiva.

U.S. Patent No. 5,807,357 to Kang discloses a small nebulizer for treating the eye, comprising a goggle unit having an air hole and at least one air chamber that is in communication with the air hole and is fitted over the user's eye. Describe. A plurality of exhaust holes are made in the goggle unit for air exhaust.

Skiba's U.S. Application No. 2002/0124843 is worn around the eye, having one or more mist outlets of an atomizer for spraying the drug into the mist so that the mist is released from the mist outlet and delivers the drug to one or more eyes. Describe the mask to be used.

U.S. Patent No. 2007/0265505 to Guillon describes an eye sheath configured to provide an enclosed area around the user's eyes, a means for holding the eye sheath in place, and a means for supplying dry air to the eye sheath.

summary

The present inventors, in particular, carbon dioxide (CO ₂ ), oxygen (O ₂ ), nitrogen oxides (NO), ozone (O ₃ ), nitrogen, fluorocarbons and perfluorocarbons, such as hydrocarbons including sulfur hexafluoride A therapeutic gas, and a mixture of nitrogen oxides and oxygen comprising a mixture of 50% nitrogen oxides and 50% oxygen, a mixture of helium and oxygen, also known as heliox, and a combination of therapeutic substances such as medical air, the cornea. It has been recognized that there is a need in the art for methods and devices that allow delivery over long periods of time, through surfaces of the eye, such as, sclera, and conjunctival surfaces. New therapeutic techniques, such as applying therapeutic forces to the anterior part of the eye, can supplement pharmacological therapy. By combining therapeutic substances and new technologies, improved patient outcomes can be realized.

This document describes, in particular, a method and apparatus for introducing a gaseous fluid into the eye to treat eye diseases. Such a method may include providing a sheath. The sheath can be sized and shaped to seat around the eye and form a cavity within the sheath. A gaseous fluid other than ambient air can enter the cavity and provide treatment to the eye. The gaseous fluid may include a specific non-ambient concentration of at least one of carbon dioxide (CO ₂ ), oxygen (O ₂ ), or nitrogen oxides (N ₂ O).

An overview of certain non-limiting aspects of the subject matter is provided below.

Aspect 1 is a claim subject (e.g., an apparatus, system, device, method, means for performing an action, or a device performing an action when implemented by the device, such as a device for maintaining the environment above the anterior surface of the patient's eye. Or a device-readable medium containing instructions that can be used. The sheath has a size and shape capable of seating around the patient's eye and forming a cavity within the sheath. The sheath can be configured to contain a fluid other than ambient air, so that the fluid can contact the patient's eye. A fluid regulator can communicate with the enclosure. The fluid regulator can be configured to adjust the composition of the fluid contained within the enclosure.

Aspect 2 may optionally include or utilize an enclosure configured to maintain differential fluid pressure between the cavity and the surrounding environment, incorporating, utilizing, or optionally in combination with the subject matter of aspect 1, wherein the fluid regulator is contained within the enclosure. It is configured to regulate the differential pressure of the fluid.

Aspect 3 may include or use the subject matter of one or any combination of aspects 1 or 2, or may be optionally combined with, to selectively include or utilize a fluid that may include a gaseous fluid.

Aspect 4 comprises or uses the subject matter of any one or any combination of aspects 1 to 3, or optionally in combination with, optionally comprising or utilizing a gaseous fluid, wherein the gaseous fluid is carbon dioxide (CO ₂ ) , Oxygen (O ₂ ), or nitrogen oxides (NO).

Aspect 5 includes or uses the subject matter of one or any combination of aspects 1 to 4, or optionally in combination with, optionally comprising or utilizing a gaseous fluid, wherein the gaseous fluid is carbon dioxide (CO ₂ ) Contains a specific non-peripheral percentage of.

Aspect 6 comprises or uses the subject matter of one or any combination of aspects 1-5, or optionally in combination therewith, optionally comprising or utilizing a gaseous fluid, wherein the gaseous fluid is oxygen (O ₂ ) Contains a specific non-peripheral percentage of.

Aspect 7 includes or uses the subject matter of one or any combination of aspects 1-6, or optionally in combination with, optionally comprising or utilizing a gaseous fluid, wherein the gaseous fluid is nitrogen oxide (NO) Contains a specific non-peripheral percentage of.

Aspect 8 is configured to detect at least one of an indicator of the eye or an indicator of a parameter of the environment within the cavity, comprising or using, or optionally in combination with, the subject matter of one or any combination of aspects 1-7. Sensors may be optionally included or used.

Aspect 9 may include or use the subject matter of one or any combination of aspects 1 to 8, or optionally in combination with, to selectively include or use a sensor, wherein the sensor is optical coherent tomography (OCT) Including the system.

Aspect 10 may include or use the subject matter of one or any combination of aspects 1 to 9, or optionally in combination with, to selectively include or use a sensor, the sensor comprising a non-contact vascular characteristic detector.

Aspect 11 may include or use the subject matter of one or any combination of aspects 1 to 10, or optionally in combination with, to selectively include or use a sensor, wherein the sensor is a quartz crystal nanobalance sensor. ).

Aspect 12 comprises or uses the subject matter of one or any combination of aspects 1-11, or optionally in combination therewith, optionally comprising or utilizing a sensor, the sensor comprising a non-invasive optical oxygen sensor do.

Aspect 13 may include or use the subject matter of one or any combination of aspects 1 to 12, or optionally in combination with, to selectively include or use a sensor, the sensor comprising a salinity sensor.

Aspect 14 may include or use the subject matter of one or any combination of aspects 1 to 13, or optionally in combination with, to selectively include or use a sensor, wherein the sensor is an aptamer-based sensor. Includes.

Aspect 15 may optionally include or utilize a processor module in communication with at least one of a fluid regulator or sensor, including or using, or optionally in combination with, the subject matter of one or any combination of aspects 1-14. .

Aspect 16 may include or use the subject matter of one or any combination of aspects 1-15, or optionally in combination with, to selectively include or utilize a processor, the processor module being in communication with a fluid regulator.

Aspect 17 may include or use the subject matter of one or any combination of aspects 1-16, or optionally in combination with, to selectively include or utilize a processor, the processor unit being in communication with the sensor.

Aspect 18 may optionally include or utilize a pump in communication with at least one of a processor or an enclosure, including or using, or optionally in combination with, the subject matter of one or any combination of aspects 1-17.

Aspect 19 includes or uses or is optionally combined with the subject matter of one or any combination of aspects 1 to 18, optionally including or utilizing a pump, the pump being in communication with the processor.

Aspect 20 may optionally include or utilize a pump, including or using the subject matter of one or any combination of aspects 1-19, or optionally in combination therewith, the pump being in communication with the enclosure.

Aspect 21 may optionally include or utilize a pump, including or using the subject matter of one or any combination of aspects 1 to 20, or optionally in combination therewith, wherein the pump is a vacuum pump.

Aspect 22 comprises a claimed subject matter (e.g., an apparatus, system, device, method, means for performing an action, or a device-readable medium comprising instructions that, when executed by the device, cause the device to perform an action), or Optionally include or use a sheath having a size and shape capable of being used or in combination with the subject matter of any one or any combination of aspects 1 to 21 to seat around the patient's eye to form a cavity within the sheath Or can provide. In the exterior, a fluid other than ambient air can be provided to the cavity to treat eye diseases, for example.

Aspect 23 optionally comprises or uses or is optionally combined with the subject matter of one or any combination of aspects 1 to 22 to provide a fluid for maintaining a differential fluid pressure between the cavity and the surrounding environment. It can be included or used as.

Aspect 24 may optionally include or utilize the subject matter of one or any combination of aspects 1 to 23 comprising or using, or optionally in combination with, sensing an indicator of a fluid other than ambient air within the cavity. .

Aspect 25 may optionally include or use sensing, including or using, or optionally in combination with, the subject matter of one or any combination of aspects 1 to 24, and sensing the indicator is fluid pressure, fluid And sensing at least one indicator of partial pressure, fluid concentration, or fluid humidity.

Aspect 26 may optionally include or use sensing, including or using the subject matter of one or any combination of aspects 1 to 25, or optionally in combination therewith, and detecting an indication of fluid partial pressure It includes sensing the fluid partial pressure of at least one of carbon dioxide (CO ₂ ), oxygen (O ₂ ), nitrogen oxides (NO), ketones, glucose, oxygen levels, dissolved salts, or vascular endothelial growth factors.

Aspect 27 may optionally include or use sensing, including or using, or optionally in combination with, the subject matter of one or any combination of aspects 1-26, wherein detecting an indicator of fluid concentration comprises: It includes sensing the concentration of at least one of carbon dioxide (CO ₂ ), oxygen (O ₂ ), nitrogen oxides (NO), ketones, glucose, oxygen levels, soluble salts, or vascular endothelial growth factors.

Aspect 28 may optionally include or use detecting an indicator of a patient's eye, including or using, or optionally in combination with, the subject matter of one or any combination of aspects 1 to 27.

Aspect 29 may optionally include or use sensing, including or using, or optionally in combination with, the subject matter of one or any combination of aspects 1 to 28, and detecting an indicator of the patient's eye is intraocular pressure. And detecting at least one of an indicator of, an indicator of carotid artery pressure, or an indicator of intracranial pressure.

Aspect 30 may optionally include or utilize sensing, including or using, or optionally in combination with, the subject matter of one or any combination of aspects 1 to 29, and detecting an indicator of carotid pressure And detecting at least one indicator of a deflection of the plate, a change in the deflection of the saphenous plate, or a change in blood vessel characteristics.

Aspect 31 may optionally include or utilize the subject matter of any one or any combination of aspects 1 to 30 including or using, or optionally in combination with, adjusting an indicator of a fluid other than ambient air.

Aspect 32 may optionally include or utilize the subject matter of one or any combination of aspects 1 to 31, or optionally in combination with, adjusting, wherein adjusting the indicator is fluid pressure, fluid And adjusting at least one indicator of partial pressure, fluid concentration, or fluid humidity.

Aspect 33 comprises or uses the subject matter of one or any combination of aspects 1 to 32, or optionally in combination with carbon dioxide (CO ₂ ), oxygen (O ₂ ), nitrogen oxides (NO), ozone. (O ₃ ), nitrogen, hydrocarbon, helium, sulfur hexafluoride, medical air, or a gaseous fluid including a gaseous fluid having a specific non-ambient concentration of at least one of water vapor may be optionally included, used or provided.

Aspect 34 comprises or uses the subject matter of any one or any combination thereof of aspects 1 to 33, or optionally in combination with Fuchs' dystrophy, glaucoma, dry eye syndrome, diabetic retinopathy, Patients with eye diseases including at least one of cataracts, venous and arterial obstruction diseases, macular degeneration, cornea, endothelial and epithelial diseases, retinal vascular diseases, retinal pigment epithelium diseases, corneal infections, or other infections of the eye. It can be selectively included or used to accommodate.

Aspect 35 may optionally include or utilize providing, including or using the subject matter of one or any combination of aspects 1 to 34, or in an alternatively combined with, providing, and providing a fluid from 30 percent to And providing a gaseous fluid at a partial pressure of 100 percent oxygen (O ₂ ).

Aspect 36 comprises or uses the subject matter of one or any combination of aspects 1 to 35, or optionally in combination with, optionally comprising or utilizing a gaseous fluid, wherein the gaseous fluid is a specific concentration of carbon dioxide ( CO ₂ ).

Aspect 37 includes or uses the subject matter of one or any combination of aspects 1 to 36, or optionally in combination with, optionally comprising or utilizing a gaseous fluid, wherein the gaseous fluid is a specific concentration of nitrogen oxides. Includes (NO).

This'problem solving means' is intended to provide an overview of the subject matter of this patent application. It is not intended to provide an exclusive or comprehensive description of the invention. The detailed description is included to provide additional information regarding this patent application.

In drawings that are not necessarily drawn to scale, like numbers may describe similar elements in different drawings. Similar numbers with different letter suffixes may indicate different cases of similar elements. The drawings generally show, by way of example, but by way of non-limiting example, of various embodiments described in this document.
1A shows an example of a device for introducing a therapeutic gas into an eye, for example.
1B shows an example of a manifold attached to the device of FIG. 1A, for example.
2A shows a first example of a wicking gasket.
2B shows a second example of an absorbent gasket.
3 shows a cross section of an exemplary absorbent gasket attached to the sheath.
4 shows a bottom view of an exemplary absorbent gasket having a suction tube, wherein the absorbent gasket is attached to the sheath.
5 illustrates an exemplary method for introducing a gaseous fluid other than ambient air into one or more cavities within an enclosure.
6 shows an exemplary method of sensing an indicator with a device.
7 shows an exemplary method for changing the composition of a gaseous fluid within a cavity.
8 shows an exemplary method for accommodating a patient.
9 shows an example of treatment with Fuchs endothelial dystrophy.
10 shows an exemplary method for introducing a gaseous fluid into a cavity with a positive gauge pressure.
11 shows an exemplary method for introducing a gaseous fluid into a cavity with negative gauge pressure.
12 shows an exemplary method for controlling the water vapor level in a cavity.

This document describes examples of devices and methods for establishing, maintaining, and controlling a treatment environment in contact with a patient's eye, for example to simultaneously provide different treatment modalities for the treatment of eye diseases.

In an example, the device may include goggles, such as a pair of goggles, positioned over the eye of a patient. Goggles, when the sheath can be positioned over the patient's eye, the sheath that forms a cavity, such as a cavity between the patient's inner surface and the inner surface of the sheath, and that delivers a fluid to the cavity, including, for example, a fluid other than ambient air. It may include a fluid regulator to control it. An environment such as a treatment environment may be established within the cavity, for example to treat an eye disease associated with the patient's eye. The treatment environment that needs to be maintained within the cavity can be determined by the eye disease to be treated. In an example, the treatment environment within the cavity can be characterized by system parameters.

In an example, the device may include a goggles, a fluid regulator, a sensor in proximity to the goggles, a pump in fluid communication with the goggles, and a processing module in electrical communication with at least one of the fluid regulator, sensor, or pump. An environment such as a treatment environment can be built, maintained, and controlled within a cavity, for example with a closed-loop controller, for example to treat an eye disease associated with a patient's eye.

The first system parameter of the treatment environment may include a composition of fluid within the cavity, such as a composition of component fluids capable of forming a treatment environment. As the therapeutic environment may be in contact with the surface of the eye, the partial pressure of one or more component fluids within the cavity will be utilized to treat eye diseases, for example through absorption of one or more component fluids through the anterior portion of the eye. I can. In an example, corneal swelling, for example associated with Fuchs endothelial dystrophy, is treated by exposing the cornea to a treatment environment, such as a treatment environment with a non-peripheral volume concentration of gaseous oxygen (O ₂ ). Can be. In an example, the treatment environment within cavity 112 may be applied to the eye at ambient pressure, for example the pressure within cavity 112 may be equal to or approximately equal to the pressure of the environment surrounding sheath 110.

A second system parameter of the treatment environment may include a gauge pressure of the treatment environment, such as a differential pressure between the treatment environment and the periphery within the cavity. Eye diseases can be treated by using the gauge pressure of the fluid in the cavity, for example by applying a mechanical force to the eye. In an example, glaucoma symptoms such as elevated intraocular pressure or carotid arterial pressure are caused by applying negative gauge pressure to the cavity, for example, to reduce intraocular pressure by allowing volume expansion of the eye or equalize carotid pressure in the patient's eye Can be treated.

In an example, a combination of system parameters such as gauge pressure and fluid composition can be used to improve the treatment of eye diseases, for example by simultaneously treating eye diseases in more than one treatment modality. In an example, macular edema due to fluid accumulation in the macula of the eye, for example, a positive gauge pressure to equalize the carotid pressure difference in the eye, and carbon dioxide (CO ₂ ) or nitrogen oxides to reduce the edema of the macular It can be treated in a therapeutic setting with a combination of therapeutic fluids, such as substances known to increase vasodilation, comprising a non-peripheral volume concentration of at least one of (NO).

1A shows an example of a device 100 for forming a therapeutic environment over an eye, for example. The device 100 includes, for example, an enclosure 110 such as a first enclosure 110A and a second enclosure 110B, which is in communication with the processor module 140, a fluid regulator 120, a sensor 130, and a processor. It may include a module 140, and a pump 150.

The sheath 110 may have a size and shape to surround the patient's eye and, for example, to be spaced apart from the eye without contacting the eye. The sheath 110 may form an enclosed cavity 112, such as a cavity 112 between the inner surface of the sheath 110 and the patient's eye when the sheath 110 is disposed with respect to the patient. The sheath 110 may be made of an optically transparent material, for example, in order to allow the patient to see the outside through the sheath 110 or to observe the eye inward through the sheath 110. . The inner surface of the exterior 110 may be treated with an anti-fog coating, for example, to prevent condensate from obstructing the patient's vision. The sheath 110 may include a hole 113 such as a plurality of holes 113 to allow drainage of condensate from the cavity 112. For example, the diameter of the hole 113 can be varied, for example in the range of about 1 mm to about 10 mm. The exterior 110 may include a gasket 114 such as a gasket positioned around at least a portion of the circumference of the exterior 110. The sheath 110 may be placed over the eye, for example a gasket 114 may be positioned against the patient's skin, thereby forming a hermetic seal between the sheath 110 and the skin, for example, (112) can be isolated from the surrounding environment. In an example, the gasket 114 may include an absorbent gasket 160, for example, a gasket capable of receiving and holding a fluid such as condensate that may appear within the cavity 112 during operation of the device 100. .

2A shows a first example of the suction gasket 160. The absorbent gasket 160 may include an absorbent core 162 having a first surface 163, and a core cover 166 having an inner surface 167 and an outer surface 168. The absorbent gasket 162 and the core cover 166 may be in contact with the skin, for example, at least a portion of the first surface 163 and the outer surface 168 are in contact with the skin, so that water in the cavity 112, It can absorb condensate, such as sweat or other liquid fluids. Removing excess condensate from cavity 112 can improve patient comfort during use of device 100.

The absorbent core 162 may be composed of an absorbent material, such as a material capable of using capillary action to transfer fluid from a first position to a second position, such as expanded polytetrafluoroethylene (or PTFE). . The core cover 166 may be composed of a porous material, for example a material having a porosity selected to achieve a certain speed of movement of the condensate through the absorbent gasket 160, such a material, for example, for a long period It is selected to minimize discomfort caused by the exterior 110 when it is placed against the skin. In an example, the core cover 166, eg, the inner surface 167, may encapsulate a specific portion or percentage of surface area of the absorbent core 162, eg, at least the first surface 163.

2B shows a second example of the suction gasket 160. The core cover 166 can substantially encapsulate the absorbent core 162 and extends through the core cover 166, for example from the inner surface 167 to the outer surface 168, a receiving hole 165 , For example, it may include a plurality of receiving holes 165. In order to remove the condensate from the cavity 112, the receiving hole 165 may arrange the absorbent core 162 in communication with the cavity 112, for example, the condensate is transferred from the cavity 112 to the receiving hole ( It may flow to the absorbent core 162 through 165.

3 shows a cross section of an exemplary absorbent gasket 160 attached to the sheath 110, for example around the sheath 110. In operation, the absorbent gasket 160 may be positioned relative to the patient, for example in contact with the patient's skin, thereby separating the cavity 112 from the surrounding environment. The absorbent core 162 communicates with the cavity 112 to absorb the accumulated condensate, for example, through the receiving hole 165. In an example, the absorbed condensate may travel through the absorbent core 162 and core cover 166 and thus evaporate from the outer surface 168 exposed to the surrounding environment, for example.

4 shows a bottom view of an exemplary absorbent gasket 160 having a suction tube 169, wherein the absorbent gasket 160 is attached to the sheath 110. In an example, the suction tube 169 may be attached to the core cover 166 and the lumen of the suction tube 169 may be in communication with the absorbent core 162. A negative gauge pressure may be generated within the lumen of the suction pipe 169 and may be applied to the surface of the absorbent core 162, and thus, for example, the absorbent core of the condensate absorbed by the absorbent core 162 Movement through 162 to suction tube 169 is caused, for example to remove condensate from cavity 112. The negative gauge pressure can be created by a condensate pump attached to the suction tube 169. In an example, the condensate pump may include a pump separate from the device 100, for example a standalone pump capable of generating a vacuum, and a pump included in the device 100, such as the pump 150.

For example, with an adjustable strap attached to the sheath 110, the sheath 110 can be secured to the patient to position the sheath 110 over the patient's eye, and such an adjustable strap substantially surrounds the head.

The sheath 110 may maintain a differential fluid pressure, such as a gauge pressure, between the cavity 112 and another pressure region such as the atmosphere surrounding the sheath 110. The fluid contained within the cavity 112 may apply pressure to the anterior surface of the eye, for example, applying a therapeutic force to the eye to treat an eye disease. In an example, positive gauge pressure can apply a therapeutic compressive force to the eye, e.g., increasing the intraocular pressure (or IOP) of the eye. In an example, negative gauge pressure can apply a therapeutic vacuum to the eye, for example reducing the eye's IOP.

The cavity 112 may contain, in contact with the eye, a fluid, such as a treatment fluid, including a fluid other than ambient air. The therapeutic fluid can be absorbed by the eye, for example through the anterior surface of the eye, to treat eye diseases. In an example, the therapeutic fluid may consist of medical fluids such as liquid fluids and gaseous fluids.

Therapeutic fluids may include miscible solutions such as aqueous solutions, and medical fluids such as liquid fluids including colloidal suspensions. Aqueous solutions may contain therapeutic substances such as vitamins or drugs dissolved in water. In an example, the drug may include anesthetic eye drops, antibiotics, or substances for diagnosing and treating glaucoma. In an example, the treatment fluid can be aerosolized, for example to create a haze or haze of the treatment fluid.

The therapeutic fluid may comprise a medical fluid, for example a gaseous fluid comprising a therapeutic gas. The treatment gas is carbon dioxide (CO ₂ ), oxygen (O ₂ ), nitrogen oxides (NO), ozone (O ₃ ), nitrogen, helium (He), hydrocarbons including fluorocarbons and perfluorocarbons, sulfur hexafluoride. , And a treatment gas. In an example, the treatment gas may comprise a mixture of at least one of carbon dioxide, oxygen, or nitrogen oxides. In an example, the treatment gas is a mixture of nitrogen oxides and oxygen including a mixture of 50% nitrogen oxides and 50% oxygen, a mixture of helium and oxygen (also known as heliox), medical air, such as medical grade air USP It may include. In an example, the combination of treatment gases may comprise a mixture of nitrogen oxides and oxygen, for example a mixture of 50% nitrogen oxides and 50% oxygen including a gas provided by the BOC Group plc under the trade name ENTONOX. In an example, the mixture may comprise a mixture of helium and oxygen, for example a mixture of 21% oxygen and 79% helium, also known as heliox.

The combination of applying a therapeutic fluid, such as other than ambient air, to the cavity 112 at gauge pressure, for example to create a therapeutic force on the eye, allows simultaneous, multi-modal therapeutic treatment of the patient's eye. can do. In an example, to improve circulation and removal of fluid from the macula, applied with a gauge pressure, for example a positive gauge pressure, within the cavity 112 to apply a compressive force to the eye with a therapeutic fluid to reduce macular edema. Combination of therapeutic fluids such as vasodilators comprising a non-peripheral volume concentration of at least one of carbon dioxide (CO ₂ ) or nitrogen oxides (NO) to treat eye diseases, such as macular edema or fluid accumulation in the macula of the eye. It can improve the treatment of eye diseases and the quality of life of the patient.

The sheath 110 may include a port 116, such as a port 116 located within the surface of the sheath 110. Port 116 may include a septum, such as a septum, that can reseal the needle perforation to allow the instrument to enter into cavity 112 while maintaining gauge pressure within cavity 112. In an example, a needle of a syringe may be inserted into or through the septum, for example to place the therapeutic fluid in contact with the eye while maintaining the gauge pressure in the cavity 112.

For example, in order to change the temperature of the treatment fluid in the sheath 110 from a first temperature to a second temperature, the sheath 110 may comprise a temperature control device. The external temperature control device increases the fluid temperature by heating the treatment fluid in the cavity 112, for example to change the vasodilating properties of the eye or the treatment fluid, and thus, for example, to increase vasodilation in the eye. I can. The therapeutic fluid may be heated within the sheath 110 by, for example, conduction using an electrically resistive heating element in contact with one or more surfaces of the sheath 110. In an example, the electrical resistive heating element may contact the generally concave inner surface of the sheath 110, the generally convex outer surface of the sheath 110, or the sheath 110, such as between the inner and outer surfaces of the sheath 110. ) Can be embedded within. The electrical resistance heating element may be electrically connected to a power source, such as the processor module 140 or a wall outlet.

In an example, the device 100 may include a first sheath 110A and a second sheath 110B, for example to form a pair of goggles. The sheaths 110A and 110B can be joined together by a bridging portion 119, such as an adjustable bridging portion that can be fitted to a particular patient. The bridge part 119 may include a pressure tube 117C connected to the sheaths 110A and 110B, for example, a cavity 112A formed by the sheath 110A is a cavity 112B formed by the sheath 110B. ) And can be in fluid communication. In an example, the fluid pressure in cavity 112A may be equal to or approximately equal to the fluid pressure in cavity 112B. In an example, the sheath 110 may have a size and shape to enclose two patient eyes, where the cavity 112 will communicate simultaneously with both eyes, for example in a manner similar to a diving face mask. I can.

The fluid regulator 120 may regulate a fluid flow between two storage containers, for example, a fluid flow between a first storage container at a first pressure and a second storage container at a second pressure different from the first pressure. . The fluid regulator 120 may include a valve to regulate the flow rate between the first and second storage containers, for example. The valve may comprise a passive valve, such as a check valve that closes when the pressure exceeds a threshold value. In an example, a fluid regulator 120A with a check valve may be located between the sheath 110A and the fluid source 170, and the pressure of the fluid source 170 may cause a threshold value, e.g., damage to the patient's eye. In the event of exceeding the possible pressure, the check valve can be closed to isolate the pressure of the fluid source 170 from the patient's eye, protecting the patient's eye from excessive force. The valve may comprise an active valve, for example a servo (or electro-modulating) valve. In an example, the servo valve may receive a control signal, for example from a control circuit, to modulate the position of the servo spool with respect to the valve body, thereby regulating, for example, fluid flow through the valve.

A fluid regulator 120 may be attached to the fluid source 170, thereby regulating fluid flow from, for example, the fluid source 170 to the cavity 112. Fluid source 170 may comprise a storage container, for example a storage container for pressurized treatment fluid. The storage container may comprise a disposable or recyclable container, eg a single-use cartridge, or a refillable container, eg a multi-use container or cartridge. Fluid source 170 may comprise a generator device, for example a device that condenses or distills a treatment fluid from another fluid. In an example, the generator device may comprise a concentrator, for example an oxygen concentrator or a carbon dioxide concentrator. In an example, the generator device may comprise an atomizer, such as an ultrasonic humidifier or an aerosolizing device, thereby discharging a therapeutic fluid, such as a miscible solution or colloidal suspension, into a therapeutic gas, such as a therapeutic mist or mist. Can be converted.

A fluid regulator 120 can be connected to the device 100, so that, for example, the output of the fluid regulator 120 can be placed in communication with the cavity 112. In an example, the fluid regulator 120A may be connected to the sheath 110A by, for example, a pressure tube 117D in direct communication with the sheath 110A. In an example, the fluid regulator 120B may be connected to a pressure tube 117B in communication with the sheath 110B by a tube connector 118, for example a Y-connector. In an example, the fluid regulator 120C may be connected to the processor module 140, thereby communicating with the enclosure 110A by, for example, a pressure tube 117A connected to the processor module 140.

The indicators of the eye may include characteristics of the eye, such as physical properties, which may change over time due to, for example, physiological changes in the eye or in response to treatment applied to the eye. Physical properties of the eye include intraocular pressure (or IOP), carotid pressure difference (or TPD), optic nerve-to-disc ratio, the diameter of blood vessels in the eye, for example, changes in the diameter of blood vessels, Alternatively, it may include at least one of a displacement of the finish plate, for example, a change in the displacement of the finish plate.

An indicator of the environment, such as a treatment environment within cavity 112, may include properties of the treatment fluid. The properties of the treatment fluid may be, for example, within the cavity 112, from the treatment fluid flow, humidity, pressure, temperature, gas, such as gas composition or partial pressure fraction, or from a biomarker, such as the eye. It may contain at least one of the body substances that are released into the cavity 112.

The sensor 130 may detect an indicator, for example, an indicator of an eye and an indicator of a treatment environment. Detecting changes in the indicators of the eye, such as those of the eye, can quantify the progression of the eye disease and the effectiveness of the applied treatment. In an example, the characteristic of the eye, e.g., the optic nerve-to-papillary depression ratio, is a first that may suggest the presence of glaucoma from an eye disease, e.g., the first optic nerve-to-papillary depression ratio in the first IOP. It can be changed due to a change in the second optic nerve-to-papillary depression ratio in the second IOP that is larger than the IOP. Treatments applied to treat eye diseases can also change the indices of the eye, for example glaucoma treatment applied to the eye, for example by lowering the IOP in the eye, thereby reducing the second optic nerve-to-papillary depression ratio. 1 It can be changed with the optic nerve-to-nipple depression ratio.

Physical characteristics of the eye may be detected by the sensor 130. For example, the sensor 130 may include, for example, a slit lamp with or without magnification, an imaging device such as a digital camera, an optical coherent tomography (OCT) imaging system, or a vascular characteristic detector, for example The human eye, in combination with the detectors and methods described in U.S. Patent Application No. 62/210,751 filed Aug. 27, 2015 by Berdahl, which is incorporated herein by reference in its entirety, may be included.

The sensor 130 may be located on the outside of the eye, for example close to but spaced apart from the device 100. In an example, using a sensor 130, for example an OCT imaging system, a first disease of the eye, e.g., a first position of the sacral plate at the first intraocular pressure (IOP), and a second disease of the eye, For example, the second position of the mapping plate in the second IOP may be detected. In an example, using the sensor 130, for example, a blood vessel characteristic detector, characteristics of blood vessels, for example, the first diameter of the extrascleral blood vessel in the first IOP and the second diameter of the extrascleral blood vessel in the second IOP Can be detected. OCT and vascular characteristic detectors can be used in offices, e.g., offices of medical professionals, for use during periodic eye examinations, e.g. to document the progression of chronic ocular diseases and to present treatment regimens to address ocular conditions. Can be located.

The sensor 130 may be located inside the eye, for example in the intraocular space of the eye. The sensor 130 may include a device capable of detecting pressure, for example, the IOP of the eye to which the sensor 130 is implanted. The sensor 130 may be located in the intraocular space of the eye to detect the first IOP of the eye with the first disease of the eye and the second IOP of the eye with the second disease of the eye, and accordingly, for example The effect of the gas therapy treatment delivered to the eye by the device 100 can be determined. In an example, sensor 130 is a sensor system, such as U.S. Patent No. 13/818,497, filed February 22, 2013 by Ostermeier, which is incorporated herein by reference in its entirety, and June 26, 2014. "WIT eye pressure measurement system from Implandata Ophthalmic Products GmbH ("An Implantable Intraocular Pressure Transducer Initial Safety Outcomes", by Melki, et at., JAMA Ophthalmology), published online and incorporated herein by reference in its entirety. Hannover, Germany)". The sensor 130 located within the eye is a controller, for example a closed loop controller, to improve patient care, to change the composition and pressure of the treatment environment, for example the treatment fluid, for example the device 100 ) For use during the treatment of an eye disease, an indicator of the eye, for example, continuous detection of IOP.

The sensor 130 may detect at least one of an indicator of the treatment environment within the cavity 112, for example, a property of the treatment fluid in contact with the eye, for example, treatment fluid flow, humidity, pressure, temperature, or medical fluid concentration. I can. The sensor 130 may be positioned in proximity to the device 100, for example in communication with the cavity 112, and for use as a feedback parameter in a closed-loop control system, for example Can provide detection. An indicator of the treatment environment may be received by the processing module 140, for example a PID controller, thereby determining the composition and pressure of the treatment fluid in the cavity 112, for example by a medical professional for the treatment of eye diseases. It can be controlled according to the treatment regimen prescribed.

The sensor 130 may include a flow sensor, for example a device for sensing an indication of the flow of the treatment fluid introduced into the cavity 112. The sensor 130 may include a humidity sensor, for example a device for sensing an indication of the relative humidity of the treatment fluid within the cavity 112. The sensor 130 may comprise a pressure sensor, for example a device for sensing an indication of the pressure of the treatment fluid within the cavity 112. The sensor 130 may include a device for sensing an indicator regarding the temperature of the treatment fluid within the cavity 112, for example a thermometer.

The sensor 130 may comprise a gas sensor, eg, a device for sensing an indicator of a gaseous material in the treatment fluid, eg, a percent concentration of gaseous material in the treatment fluid. In an example, the gaseous substance may comprise a component of a medical gas, such as a therapeutic fluid that is delivered to the cavity 112. In an example, the gaseous substance may include biomarkers, such as biomarkers released by the eye.

Biomarkers are ketones that can be detected with a volatile gas sensor, including, for example, a quartz crystal nanobalance (QCN) sensor, e.g., glucose, which can be detected with an optical glucose sensor including an OCT imaging system. For example, oxygen levels that can be detected with a non-invasive optical oxygen sensor, e.g., dissolved salts that can be detected with a salinity sensor, and, for example, a publication published in February 2012, which is incorporated herein by reference in its entirety. ["Flexible FET-Type VEGF Aptasensor Based on Nitrogen-Doped Graphene Converted from Conducting Polymer", by Kwon, et at., ACS Nano, Vol. 6, #2, pages 1486-1493]. Vascular endothelial growth factor (or VEGF), which can be detected with an aptamer-based sensor. The biomarker is a physiological condition of the eye, eg, where medical intervention may be required. For example, a stability state or a fatigue state can be suggested.

The sensor 130 may comprise a pulse oximeter device, for example a device for detecting an indicator of systemic oxygen level. In an example, an indicator of systemic oxygen level can be received by the processing module 140, and the oxygen concentration in the treatment fluid can be adjusted, e.g., increased, to maintain the oxygenation of the eye even when a low systemic oxygen level is present. Can be.

The processor module 140 may provide a communication interface so that, for example, a user may operate the device 100. The communication interface may include, for example, an operation unit so that a user can manage basic functions of the device 100, for example, the cycling of power of the device 100. The communication interface may include a data acquisition unit for recording an indicator, for example an indicator of a therapeutic fluid within the cavity 112 or an indicator of an eye over a period of time. In an example, the indicator may be recorded for a relatively short period of time, eg for health examination purposes, or for a relatively long period of time, eg to monitor the effect of a prescription treatment on the eye disease being treated.

The processor module 140 may control the operation of the device 100, for example, the device may be operated in a feedback or closed-loop control mode. The processor module 140 may communicate with, for example, electrical communication with at least one of the regulator 120, the sensor 130, or the pump 150 in order to coordinate with the operation of the component. The processor module 140 may receive a signal, e.g., a signal proportional to an indicator of snow or environment, from the sensor 130 and process the signal, for example, to compare a first signal and a second signal, Thus, for example, it is possible to find a difference between the first and second signals. The processor module 140 may include a control circuit, and accordingly, may implement a control algorithm including, for example, a feedback control algorithm. In an example, the control circuit may comprise a controller, for example a proportional-integral-differential (or PID) controller. In operation, the control circuit may receive a signal from the sensor 130, e.g., an electrical signal proportional to the change in the detected indicator, and process the signal with, for example, a PID controller to process the sensor signal and setpoint, e. For example, it is possible to minimize steady state errors between certain user-defined set points, and to adjust the operating state of at least one of, for example, regulator 120, manifold spout 144, or pump 150. To do this, you can generate a control signal.

The processor module 140 may include a power source for supplying electrical energy to the device 100, for example. In an example, the power source may include a battery, for example a lithium ion battery, and a transformer for receiving power from a wall outlet for use in the device 100, for example at a specific voltage and current. The processor module 140 may include a heating element, for example a heating element in communication with the treatment fluid, including a heating element positioned on the surface of the mixing chamber 146 to raise the temperature of the treatment fluid. .

1B shows an example of a manifold 149, for example a manifold 149 that may be in, for example, electrical communication with the processing module 140, and may be, for example, in fluid communication with the pump 150. Shows. The manifold may include a mixing chamber 146, and thus, a pressure tube 117, for example a pressure tube 117A, to fluidly connect, for example, a fluid regulator 120C and a pump outlet 155. Can be connected by In operation, through the fluid regulator 120C, the volumetric fluid flow from the pump outlet 155 is combined with the medical fluid, e.g., from the fluid source 170, and the treatment fluid within the mixing chamber 146 Can be formed. The treatment fluid can exit mixing chamber 146 through pressure tube 117A, for example, for introduction into cavity 112A.

The manifold 149 may comprise an inlet chamber 148, thereby for example connecting the pump inlet 156 to a pressure tube 117, for example a pressure tube 117B in fluid communication with the cavity 112B. And, and, for example, in fluid connection with the manifold outlet 144 in communication with the surrounding environment.

The manifold 149 may include a spout 144 in fluid communication with the cavity 112, thereby adjusting the gauge pressure within the sheath 110, for example. The spout 144 can be in communication with the processor module 140 to open and close the spout 144, thereby maintaining a desired gauge pressure within the cavity 112, for example. In an example, when the gauge pressure sensed by the sensor 130 in the cavity 112 exceeds a predetermined threshold value, the spout 144 may receive a control signal from the control circuit, and thus, for example, the cavity The spout 144 can be modulated to maintain the desired gauge pressure within 112.

In operation, the pump 150 may create a low pressure region at the pump inlet 156, thereby drawing treatment fluid from, for example, pressure tube 117B and surrounding fluid from the manifold outlet 144, for example. For example, it can draw air of standard temperature and pressure. The composition of the treatment fluid can be adjusted by the amount of ambient air drawn from the manifold outlet 144.

The pump 150 may create a volumetric fluid flow, for example by using fluid from the device 100, for example a cavity 112 or from an external source. The pump 150, for example, a passage 157 between the pump inlet 156 and the pump outlet 155, and a fan 153 located at least partially within the passage 157, for example a volumetric fluid flow. It may include a centrifugal fan that can be produced. The pump 150 includes a filter 158, for example a particulate filter for removing dust from the fluid flow in communication with the passage 157 and a dehumidifying filter for removing water vapor (i.e. moisture), and a passage 157 and surroundings. It includes a pump outlet 159 in communication with the environment, thereby allowing, for example, ambient air to be introduced into the device 100. The pump 150 may include a power source 152, for example, a battery, and may be in communication with the exterior 120, the sensor 130, and the processor module 140.

In operation, rotation of the fan 153 in the passageway 157 can draw fluid from the inlet, for example from the pump inlet 156 including the spout 144 and the pump spout 159, and thus A volumetric fluid flow can be created at the outlet, for example pump outlet 155. Filter 158 may be located within passage 157, for example between pump inlet 156 and fan 153 or between fan 153 and pump outlet 155. The exposure of the filter 158 to fluid flow can be controlled, for example the volume of fluid flow through the filter can be controlled, and parameters of the treatment fluid can be adjusted accordingly. In an example, by exposing at least a portion of the treatment fluid to a filter 158, for example a dehumidifying filter, the humidity in the treatment fluid may be adjusted, for example reduced. The exposure of the filter 158 to the treatment fluid can be controlled with a slide valve, for example a slide valve attached to the actuator and in electrical communication with the control circuit of the processing module 140. In an example, water vapor can be entrained in the dehumidifying filter, for example until the dehumidifying filter can be saturated, and after saturation, for example, by replacing the saturated dehumidifying filter 158 or, the dehumidifying filter 158 In order to evaporate water vapor from it, it can be removed from the apparatus 100 by heating the dehumidifying filter 158.

Pump 150 may apply and maintain gauge pressure within cavity 112 and dispense a fluid, such as a treatment fluid, within cavity 112. The applied gauge pressure ranges from about -40 mmHg to about 40 mmHg, for example from about -20 mmHg to about 20 mmHg, from about -10 mmHg to about 10 mmHg, from about -5 mmHg to about 5 mmHg. Range, from about -1 mmHg to about 1 mmHg, or from about -0.5 mmHg to about 0.5 mmHg. In the example, the pump 150 is -40 mmHg, -35 mmHg, -30 mmHg, -25 mmHg, -20 mmHg, -15 mmHg, -10 mmHg, -5 mmHg, -4 mmHg, -3 mmHg, -2 mmHg, -1 mmHg, -0.9 mmHg, -0.8 mmHg, -0.7 mmHg, -0.6 mmHg, -0.5 mmHg -0.4 mmHg, -0.3 mmHg, -0.2 mmHg, -0.1 mmHg, -0.09 mmHg, -0.08 mmHg,- 0.07 mmHg, -0.06 mmHg, -0.05 mmHg, -0.04 mmHg, -0.03 mmHg, -0.02 mmHg, -0.01 mmHg, 0.01 mmHg, 0.02 mmHg, 0.03 mmHg, 0.04 mmHg, 0.05 mmHg, 0.06 mmHg, 0.07 mmHg, 0.08 mmHg , 0.09 mmHg, 0.1 mmHg, 0.2 mmHg, 0.3 mmHg, 0.4 mmHg, 0.5 mmHg, 0.6 mmHg, 0.7 mmHg, 0.8 mmHg, 0.9 mmHg, 1 mmHg, 2 mmHg, 3 mmHg, 4 mmHg, 5 mmHg, 10 mmHg, 15 A gauge pressure may be applied to the cavity 112 at a level of at least one of mmHg, 20 mmHg, 25 mmHg, 30 mmHg, 35 mmHg, or 40 mmHg.

The appropriate duration for applying a therapeutic fluid, for example a therapeutic fluid applied with or without gauge pressure, may vary depending on the eye condition being treated. Treatment regimens for acute eye diseases may require application of a therapeutic fluid for a relatively short period of time, for example, with or without gauge pressure, for a period measured in minutes, hours, days, or weeks. have. In an example, the treatment regimen for treating acute eye disease is 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, 12 hours, 13 hours. Hours, 14 hours, 15 hours, 16 hours, 17 hours, 18 hours, 19 hours, 20 hours, 21 hours, 22 hours, 23 hours, and 24 hours, 1 day, 2 days, 3 days, 4 days, 5 days , 6 days, and 7 days, 1 week, 2 weeks, 3 weeks, or 4 weeks, may include applying the treatment fluid to the device 100 for at least one.

Treatment regimens for chronic eye diseases, such as glaucoma, include application of a therapeutic fluid over a relatively long period of time, for example, with or without gauge pressure, for a period measured in days, weeks, months or years. You can ask for For example, treatment regimens for treating chronic eye disease are 1, 2, 3, 4, 5, 6, and 7 days, 1 week, 2 weeks, 3 weeks, and 4 weeks, 1 Months, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months, 1 year, 2 years, 3 years, 4 years, 5 years , 6 years, 7 years, 8 years, 9 years, or 10 years, may include applying the treatment fluid to the device 100 for at least one. In an example, the treatment regimen for treating chronic eye diseases such as glaucoma and optic nerve papillary edema, for example, with or without gauge pressure, is the application of a therapeutic fluid delivered to the eye to the device 100 over the life of the patient. It may include.

The pump 150 may modulate, for example, periodically or aperiodically, the treatment fluid applied into the cavity 112, with or without gauge pressure, for example. Periodic gauge pressures may include gauge pressures that may vary in size at regular intervals, such as, for example, sinusoidal signals, periodic non-sinusoidal signals, and repetitive processes. In an example, the gauge pressure applied to the sheath 110 may be changed in a substantially sinusoidal manner with a period of about 24 hours, for example to compensate for the natural daily daily period of the IOP in the patient's eye. The periodic gauge pressure may include a gauge pressure at which frequency varies, such as the time between repetition intervals in the periodic signal. In an example, for example, when the gauge pressure applied to the cavity 112 varies according to cardiac activity, such as heart rate and blood pressure, the gauge pressure applied to the sheath may be changed in frequency, and the cardiac activity may be performed by the processing module 140 ) And is measured by a detection device such as a blood pressure monitoring device.

Aperiodic gauge pressures may include gauge pressures that vary in size at irregular intervals, such as, for example, aperiodic signals and non-repetitive processes. The gauge pressure applied to the sheath can be varied in an aperiodic manner that depends on indicators of body parameters, such as the patient's position relative to the coordinate system. In an example, the indicator of the body position may include a change in body position, for example, a change in the patient's body position transitioning from a first body position, such as an upright position, to a second body position, such as a seated or prone position. The gauge pressure applied to the exterior 110 may be changed in an aperiodic manner that varies according to the sum of one or more periodic and aperiodic signals. In an example, the gauge pressure applied to the sheath 110 may include a periodic component, such as gauge pressure due to cardiac activity, and an aperiodic component, such as gauge pressure due to a patient's body position.

5 shows an exemplary method 500 for introducing a fluid, eg, a gaseous treatment fluid other than ambient air, into the cavity 112. At 502, the sheath 110, for example a sheath 110 having a size and shape, to be seated around the eye, and thus to form a cavity 112 within the sheath 110 over the snow, for example. Can be provided. The exterior 110 may include a gasket 114 that is seated between the exterior 110 and the patient's skin to form a seal between the exterior 110 and the patient's skin. The gasket 114 may be selected to form a resistive flow path between the treatment environment within the cavity 112 and the surrounding environment, for example the resistance may vary depending on the gasket used. In an example, the gasket 114 may form a'loose' seal between the sheath 110 and the patient, thereby allowing the fluid to slightly flow from the cavity 112 through the resistive flow path to the surrounding environment, for example. It can be allowed to leak and thus maintain some gauge pressure within cavity 112, for example. In an example, the gasket 114 may form a'tight' seal between the sheath 110 and the patient, thereby allowing leakage of fluid from, for example, cavity 112 through a resistive flow path into the surrounding environment. Most can be avoided, thereby maintaining a significant gauge pressure within the cavity 112, for example. In an example, the gasket 114 may form a hermetic seal that may prevent fluid from leaking from the cavity 112 to the surrounding environment.

At 504, a fluid, such as a treatment fluid other than ambient air, may be provided to the cavity 112. The therapeutic fluid may comprise a medical fluid, for example a pure gas comprising nitrogen oxides and carbon dioxide, and a combination with a medical gas. In an example, the combination of medical gases may include a combination of nitrogen oxides and carbon dioxide, thus affecting the vasodilation of the eye, for example, by increasing the outflow of aqueous body fluids to low IOPs. The percentage of nitrogen oxides and carbon dioxide can be specified to achieve a certain endpoint, for example to maximize vasodilation of the eye based on the physiological function of a particular patient. The percentage of nitrogen oxides is a specific percentage of nitrogen oxides, for example 1%, 2%, 3%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98% 99%, or other percentages.

In an example, the combination of gases may include a combination of nitrogen oxides and oxygen, thereby increasing the vasodilation of the eye, e.g., by increasing the outflow of aqueous bodily fluids to low IOPs, while providing increased oxygen concentration to the tissue. , For example, can be provided to eye tissue. The percentage of nitrogen oxides and oxygen can be specified to achieve a certain endpoint, for example to maximize ocular tissue oxygen saturation based on the physiological function of a particular patient.

The gaseous treatment fluid may include water vapor, such as moisture. The humidity of the therapeutic fluid is a specific humidity, e.g. a specific percentage humidity (e.g., relative humidity), e.g. 1%, 2%, 3%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98% 99%, or other percentages.

The therapeutic fluid provided to the cavity 112 may be in contact with the eye, such as with an anterior surface of the eye, including the corneal, sclera and conjunctival surfaces of the eye, such that the therapeutic fluid is brought into the eye, for example of the eye. It can be delivered through absorption of the treatment fluid through the surface. The composition of the treatment fluid can be controlled, for example, with the fluid regulator 120. The fluid regulator 120 may include a passive valve, eg, a check valve that closes when the pressure exceeds a threshold value, eg, a pressure that may damage a patient's eye. In an example, if the pressure in the fluid source 170 may be below a threshold value, fluid may flow between the cavity 112 and the fluid source 170. In an example, if the pressure of the fluid source 170 is above a threshold value, the check valve may be closed, thereby preventing damage to the patient's eye, for example. In an example, a threshold value can be adjusted, for example a check valve can be adjusted from a first threshold value to a second threshold value, for example the second threshold value is different from the first threshold value.

6 shows an exemplary method 600 of sensing an indicator with the device 100. At 606, an indicator of the eye or an indicator of the environment within the cavity 112 may be sensed, for example, with the sensor 130. Detecting an indicator of the eye may include detecting changes in physical properties of the eye, for example physical properties. The physical properties may be periodically sensed and thus track the progression of an eye disease, for example as part of an eye examination, or a closed-loop control configured to adjust the composition of the therapeutic fluid within the cavity 112, for example. Feedback parameters within the system can be continuously sensed.

Detecting an indicator of the environment may include sensing a property of the treatment fluid within the cavity 112, for example a level of property or a change in level of a property. In an example, the sensor 130 may detect a level of fluid concentration or a change in fluid concentration, such as a concentration of a medical fluid in a treatment fluid. The therapeutic fluid properties can be detected periodically, for example on a daily or hourly schedule, or continuously.

7 shows an exemplary method 700 for conditioning a treatment fluid within cavity 112. At 708, the composition of the treatment fluid, eg, treatment fluid, may be changed. Altering the treatment fluid may include changing the composition of the treatment fluid, for example by changing the concentration of a component fluid, such as a medical gas, in the treatment fluid.

Changing the composition of the treatment fluid may include manually adjusting the concentration of the component fluid, for example by adjusting the valve of the fluid regulator 120. For example, when it is recognized that the symptoms of the eye disease worsen, the eye patient, for example, by increasing the flow of medical fluid into the cavity 112, until the symptoms of the eye disease disappear, By manually opening the check valve of the regulator 120, the composition of the treatment fluid provided to the cavity 112 can be changed.

Changing the composition of the treatment fluid may include operating the device 100 with an open-loop control algorithm, for example with a controller that changes the treatment composition at a predetermined time. The patient's eye pressure can vary throughout the day, for example IOP can be elevated during active hours of the day and lower during inactive hours. In an example, the device 100 can manage IOP treatment, for example with a control circuit that operates an open-loop algorithm, where the control circuit can be connected to a servo valve, and the control circuit controls the time of day. It is programmed to initiate a preset pattern on the basis of. For example, the control circuit may be configured to increase the oxygen concentration in the treatment fluid for a time when the patient may be active and to reduce the oxygen concentration in the treatment fluid for a time when the patient may be inactive. The servo valve can be adjusted.

Altering the composition of the treatment fluid includes operating the device 100 with a closed-loop control algorithm, for example a controller that changes the treatment composition in response to receiving a first feedback parameter, for example an indicator of the eye. can do. In an example, the sensor 130, for example a digital camera, may detect a change in an index of the eye, for example a change in the optic nerve-to-nipple depression ratio of the eye. The digital camera, for example, with the processing module 140, compares a first image captured at a first time instant and a second image captured at a second time instant, and compares between the first image and the second image. By identifying the difference, changes in the optic nerve-to-papillary depression ratio can be detected. A controller, for example, a PID controller, may receive a signal from the sensor 130 that is proportional to the index of the eye, and may send a control signal to, for example, the fluid regulator 120, and thus determine the composition of the medical fluid. It can be changed, for example, can be made to act in the opposite direction to the change in the optic nerve-to-nipple depression ratio sensed by the sensor 130.

Changing the composition of the treatment fluid may include receiving a second feedback parameter, such as an indication of the environment within the cavity 112. In an example, the sensor 130, eg, a gas sensor, may detect an indicator of a treatment fluid, eg, a concentration of a medical fluid. The controller may receive a signal from the sensor 130 that is proportional to the indicator of the treatment fluid and may compare the received signal to a setpoint value. If the concentration of the medical fluid falls below the set point value, the controller can send a control signal to the fluid regulator 120 to change the fluid flow of the medical fluid from the fluid source 170, for example within the treatment fluid. The medical fluid concentration can be increased and the difference between the received signal and the set point value can be minimized. If the concentration of the medical fluid exceeds the set point value, the controller may send a control signal to the pump 150, for example to the fan 153 to increase the volumetric fluid flow, e.g. in the treatment fluid. It is possible to reduce or dilute the medical fluid concentration and minimize the difference between the received signal and the setpoint value.

8 shows an exemplary method 800 for accommodating a patient. At 810, accommodating a patient may include accommodating a patient having an eye condition for treatment with a therapeutic fluid.

Eye diseases include glaucoma, dry eye, diabetic retinopathy, cataracts, venous and arterial obstruction diseases, macular degeneration, cornea, endothelial and epithelial diseases, retinal vessel diseases, retinal pigment epithelium diseases, corneal infections, or other infections of the eye An eye disease comprising a can be treated with a therapeutic fluid, and the therapeutic fluid includes at least one of a medical fluid, for example, carbon dioxide, oxygen, or nitrogen oxides. The specific non-ambient concentration of medical fluid in the treatment fluid is 1%, 2%, 3%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50 %, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98% 99%, or other percentage concentrations. I can. In an example, the treatment fluid may comprise 50 percent to 80 percent carbon dioxide (CO ₂ ), for example to treat glaucoma. In an example, the therapeutic fluid may comprise 50 percent to 95 percent oxygen (O ₂ ), for example to treat diabetes or Fuchs endothelial dystrophy. In an example, the treatment fluid may comprise 10 percent to 90 percent nitrogen oxides (NO), for example to treat glaucoma.

The exemplary method 800 can be used to treat the eye, for example synergistically with a therapeutic substance that comes into contact with the eye. Synergy can be described as an interaction between two or more therapeutic agents resulting in a pharmacological response greater than the sum of the individual responses to each agent. The first synergistic therapeutic agent may comprise a therapeutic fluid, for example at least one of riboflavin, decorin, anti-VEGF, antibiotic, antiviral or antifungal fluid. The second synergistic therapeutic agent comprises at least one of a source of radiant energy, e.g., non-interfering light, infrared (IR) light, ultraviolet (UV) light, e.g., coherent light, realized with a laser, or a medical fluid. Can include.

In an example, method 800 is a first set of therapeutic agents to treat corneal dilatation, sharp edge degeneration (PMD) and post-Lasik dilatation, including conical cornea, for example by corneal collagen cross-linking. Can be synergistic. At 810, a patient suffering from telangiectasia can be accommodated. At 502, a sheath sized and shaped for seating around the eye may form a cavity 112 over the eye. At 504, a first synergistic therapeutic agent, e.g., a gaseous fluid other than ambient air comprising a fluid having a certain concentration of riboflavin, and a second synergistic therapeutic agent, e.g., radiant energy comprising UV-A light. May be introduced into the cavity 112. Gaseous riboflavin can be absorbed into the anterior surface of the eye and exposure to UV-A light, e.g. through the sheath 110 that illuminates the eye and riboflavin-rich treatment fluid synergizes the absorbed riboflavin. And thereby improving the strength and elasticity of the cornea, for example by forming additional bonds between adjacent collagen strands in the matrix layer of the cornea. At 606, an indicator of the concentration of riboflavin can be detected within the cavity 112, thus indicating the amount of riboflavin absorbed by the eye, for example. At 708, the concentration of riboflavin can be changed, for example to a pseudo-recommended concentration, and can be increased or decreased, for example.

In an example, method 800 comprises a second set of therapeutic agents, e.g., a third therapeutic agent comprising a specific concentration of decorin and a fourth therapeutic agent comprising a specific concentration of oxygen, a first set of therapeutic agents. In the same way, it can be synergistic.

The exemplary method 800 can be used to treat the eye, and for example, prevent eye infection. Aerobic infection involves the growth of bacteria that require free oxygen, whereas anaerobic infection involves the growth of bacteria without free oxygen.

In an example, the method 800 controls the growth of an eye infection, for example by providing an oxygen-depleted environment to inhibit the growth of aerobic infections or by providing an oxygen-enriching environment to inhibit the growth of an anaerobic infection. Can be prevented. At 810, a patient suffering from an eye infection, such as an aerobic or anaerobic infection, can be accommodated. At 502, a sheath sized and shaped for seating around the eye may form a cavity 112 over the eye. At 504, a nitrogen-enriched environment comprising a therapeutic fluid other than ambient air, e.g., a therapeutic fluid comprising greater than 78% nitrogen to treat aerobic infections, and greater than 21% oxygen to treat anaerobic infections. An oxygen-enriched environment may be provided in the cavity 112 that contains the therapeutic fluid. At 606, an indicator of the environment, eg, a concentration of fluid other than ambient air, may be sensed within the cavity 112, thereby assessing the efficacy of, eg, an infection treatment. At 708, the concentration of fluid other than ambient air can be altered, for example increased or decreased, to a pseudo-recommended concentration for treating an eye infection.

Exemplary method 800 can be used to treat the eye and, for example, can minimize post-surgical damage during the healing process of the eye. In an example, a hypoxic (or oxygen-depleted) environment can reduce corneal scarring and clouding during eye recovery. Eye scarring and clouding can be minimized using methods used to treat infections, such as aerobic infections as previously disclosed.

9 shows an exemplary method 900 of treating Fuchs endothelial dystrophy. Fuchs endothelial dysfunction can occur when the cornea is swollen, for example due to endothelial cell dysfunction. Fuchs endothelial dystrophy can be treated by reducing the IOP of the eye and by removing water from the cornea, for example by applying a desiccant comprising sodium chloride and glycerin to the surface of the eye and evaporating water from the surface of the eye. I can.

At 902, a patient with an eye disease, such as Fuchs endothelial dystrophy, can be accommodated. At 904, the sheath 110 may be provided to fit over the patient's eye, thereby forming a cavity 112 between the patient's eye and the sheath 110, for example. At 906, a therapeutic fluid other than ambient air may be provided into the cavity 112 so that, for example, a therapeutic fluid may contact the surface of the patient's eye. In an example, the therapeutic fluid is a composition of a medical fluid, for example a gas having a specific non-ambient concentration of at least one of carbon dioxide (CO ₂ ), oxygen (O ₂ ), nitrogen oxides (NO), or water vapor. A therapeutic fluid having a sufficient amount of water vapor to achieve the desired relative humidity of the composition of the fluid may be included. The specific non-ambient concentration of the components of the therapeutic fluid, for example oxygen or relative humidity, is 1%, 2%, 3%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40 %, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98% 99%, or other percentages It can contain the same percentage concentration. Percent concentrations of such components can be selected for therapeutic purposes. In an example, the gaseous fluid may contain 30 percent to 100 percent oxygen (O ₂ ), for example to maintain or improve endothelial cell function diagnosed with Fuchs endothelial dystrophy. Treatment of Fuchs endothelial dystrophy, as in exemplary method 900, can be extended to patients with symptoms similar to Fuchs endothelial dysplasia. In an example, endothelial cell function in a person exposed to a high altitude or hypoxic environment, such as an astronomer, astronaut, mountaineer, or others, using a therapeutic fluid, e.g., a gaseous fluid comprising 30% to 100% oxygen. Can be maintained or improved. At 908, at least one of the first sensor 130, e.g., an OCT imaging system, may detect a change in an index of the eye, e.g., a deflection of the map for evaluating an IOP, or a second sensor ( 130), for example, a humidity sensor may detect an indicator of the environment, such as relative humidity within the cavity 112, and thus monitor the effect of the treatment fluid on the patient's eye. At 910, the composition of the therapeutic fluid, e.g., a component of the therapeutic fluid and the level of relative humidity, may be changed, e.g., by adjusting the specific non-ambient concentration of at least one of the components of the therapeutic fluid or by adjusting the relative humidity. And thereby improving treatment for Fuchs endothelial dystrophy as applied to the patient's eye, for example.

10 shows an exemplary method 1000 for introducing a gaseous fluid, such as a gaseous fluid other than ambient air, into the cavity 112 with a positive gauge pressure. In an example, a user may interact with an operating unit of the processor module 140 and may, for example, initiate an operation of the method 1000.

At 1002, the spout 144 can be opened. The opening of the spout 144 may equalize the fluid pressure in the device 100, for example the cavity 112, to the surrounding environment. Equalizing the pressure prepares the cavity 112 to receive a particular gaseous fluid, for example a treatment fluid.

At 1004, the valve of the fluid regulator 120, for example the fluid regulator 120C, may be opened. The valve opening of the fluid regulator 120C allows a fluid, e.g. medical fluid, to be in communication with the outside of the fluid source 170 and into the processor module 140, e.g. with the pressure tube 117 and pump outlet 155. It may be allowed to flow into the mixing chamber 146. In an example, the composition of the treatment fluid can be adjusted, for example by changing the outflow amount of the fluid source, for example by opening and closing the valves of the fluid regulator 120C. In an example, the valve may be opened at a predetermined rate, for example in response to a control signal from the processor module 140, and thus the concentration of medical fluid released into the mixing chamber 146 over time. Can be gradually increased.

At 1006, the pump 150 may be started to create a volumetric fluid flow, thereby creating a positive gauge pressure, for example at the pump outlet 155. In an example, the pump inlet 156 may be blocked, and the pump outlet 155 may be in direct communication with the mixing chamber 146, for example, the volume output may be provided with a medical fluid flowing through the fluid regulator 120C. Can be combined, thereby producing, for example, a therapeutic fluid. The composition of the treatment fluid may vary depending on the volume output of the pump 150 and the volume and concentration of the medical fluid flowing through the fluid regulator 120C. In an example, the composition of the treatment fluid can be adjusted, for example by changing the volume output of pump 150. For example, the volume output of the pump 150 may be changed by increasing or decreasing the speed of the pump 150, for example, the fan 153 of a centrifugal pump. The treatment fluid can flow out of the mixing chamber 146, into the cavity 112, for example through the pressure tube 117.

At 1008, a sensor 130, e.g., a gas sensor located within the cavity 112, can detect the treatment fluid flowing into the cavity 112, and thus an indicator of the concentration of the medical fluid in the treatment fluid, for example. Can be detected. The processor module 140 may receive a signal from the sensor 130, for example, an electrical signal proportional to an index of the concentration of the medical fluid in the treatment fluid. The received sensor signal can be compared with a control circuit to a predetermined setpoint value, for example a pseudo-recommended concentration of a medical fluid for the treatment of eye diseases. If the received sensor signal is less than the predetermined concentration set point value, the valve of the fluid regulator 120C may be further opened at 1007, thereby increasing the concentration of the medical fluid in the mixing chamber 146, for example, and , The treatment fluid can be re-detected at 1008. For example, the valve of the fluid regulator 120C may continue to open until a received sensor signal sensed within the cavity 112 reaches a predetermined concentration setpoint value.

At 1010, the spout 144 may be closed. After the received sensor signal has reached a predetermined set point value, the treatment fluid can be considered to be properly mixed within the device 100 at the pressure of the surrounding environment, for example at a local ambient pressure. The spout 144 may then be closed, thereby allowing the pump 150 to build up a positive gauge pressure within the device 100, for example.

At 1012, for example, for an indication of the therapeutic fluid gauge pressure, a sensor 130, eg, a pressure sensor located within the cavity 112, may sense the fluid pressure within the cavity 112. The processor module 140 may receive a signal from the sensor 130, for example, an electrical signal proportional to the gauge pressure of the treatment fluid. The received sensor signal can be compared with a control circuit to a predetermined set point value, for example a pseudo-recommended gauge pressure of a therapeutic fluid for treatment of an eye disease. If the received sensor signal is less than a predetermined gauge pressure setpoint value, the speed of the fan 153 can be increased at 711, thereby increasing the volumetric fluid flow in the mixing chamber 146, for example, The treatment fluid can be re-detected at 1013. Pump 150 may continue to produce a volumetric fluid flow until, for example, a gauge pressure sensed within cavity 112 reaches a predetermined gauge pressure set point value.

At 1014, for example, when a predetermined gauge pressure setpoint value is achieved, the pump can be stopped. Stopping the pump 150 may prevent changes in the composition of the treatment fluid, such as medical fluid concentration and gauge pressure.

At 1016, the valve in fluid regulator 120C may be closed. Closing the valve of the fluid regulator 120C may stop the medical fluid from flowing out of the fluid source 170. In an example, the valve may be closed at a predetermined rate, for example a selected rate to prevent a change in the concentration of the treatment fluid.

At 1018, sensor 130 may sense an indication of the treatment fluid within cavity 112, for example for deviations from a specific setpoint value. In an example, an indicator of the concentration of the medical fluid in the treatment fluid can be detected by a gas sensor, and with the control circuit, a pseudo-recommended concentration setpoint level and a tolerance range (or It can be compared with an error band. In an example, an indication of the positive gauge pressure in the treatment fluid can be detected by the pressure sensor, and with the control circuit, a pseudo-recommended positive gauge pressure setpoint level and a tolerance around the setpoint level, for example approximately It can be compared to a range (or error band). When the detected indicator decreases outside the tolerance range, the method 1000 may be restarted, eg, at 1004, and adjusts the detected indicator to a value within the tolerance range accordingly.

11 shows an exemplary method 1100 for introducing a gaseous fluid, eg, a gaseous fluid other than ambient air, into the cavity 112 at a negative gauge pressure. In an example, a user may interact with an operating unit of processor module 140, for example, initiating an operation of method 1100.

At 1102, the spout 144 may be closed. Closure of the spout 144 may isolate the fluid pressure in the device 100, for example the cavity 112, from the surrounding environment. Pressure isolation may prepare the cavity 112 to receive a mixture of gases other than ambient air, for example a mixture of treatment gases.

At 1104, the valve of the fluid regulator 120, for example the fluid regulator 120C, may be opened. The valve opening of the fluid regulator 120C allows the fluid, e.g., medical fluid, to flow out of the fluid source 170 and into the processor module 140, e.g., into the mixing chamber 146 in communication with the pressure tube 117. You can make it flow. In an example, the composition of the treatment fluid can be adjusted, for example by changing the outflow amount of the fluid source, for example by opening and closing the valves of the fluid regulator 120C. In an example, the valve may open at a predetermined rate, thereby gradually increasing the concentration of medical fluid that is discharged into the mixing chamber 146, for example over time.

At 1106, the pump 150 may be started to create a volumetric attraction, thereby creating a negative gauge pressure, for example at the pump inlet 156. In an example, the pump outlet 155 may be blocked, the pump inlet 156 may be in indirect communication with the mixing chamber 146, for example, the pump inlet 156 may be mixed through the pressure tube 117 It can communicate with the chamber 146. For example, the pump 150 creates a negative gauge pressure at the pump inlet 156, and the fluid in the mixing chamber 146, e.g., a medical fluid, is passed through the pressure tube 117, for example a pressure tube. It can be pulled through 117A into cavity 112A, through pressure tube 117C into cavity 112B, and through pressure tube 117B into pump inlet 156. When the medical fluid is drawn from the mixing chamber 146, the medical fluid can be combined and mixed with the fluid in the cavity 112 and the pressure tube 117, thereby creating, for example, a therapeutic fluid. The composition of the treatment fluid may vary depending on the volume and concentration of the medical fluid flowing through the volume attraction of the pump 150 and the fluid regulator 120C. In an example, the composition of the treatment fluid can be adjusted, for example by changing the volume attraction of pump 150. For example, the volume attraction of the pump 150 may be changed by increasing or decreasing the speed of the pump 150, for example a centrifugal pump.

At 1108, a sensor 130, e.g., a gas sensor located within the cavity 112, may sense the therapeutic fluid flowing through the cavity 112, and thus, for example, a concentration of the medical fluid in the treatment fluid. Indicators can be detected. The processor module 140 may receive a signal from the sensor 130, for example, an electrical signal proportional to an index of the concentration of the medical fluid in the treatment fluid. The received sensor signal can be compared with a control circuit to a predetermined setpoint value, for example a pseudo-recommended concentration of a medical fluid for the treatment of eye diseases. If the received sensor signal is less than the predetermined concentration set point value, the valve of the fluid regulator 120C may be further opened at 1107, thereby increasing the concentration of the medical fluid in the mixing chamber 146, for example, and , The treatment fluid may be re-detected at 1108. For example, the valve of the fluid regulator 120C may continue to open until a received sensor signal sensed within the cavity 112 reaches a predetermined concentration setpoint value.

At 1110, pump 150 may be stopped. After the received sensor signal has reached a predetermined set point value, the treatment fluid can be considered to be properly mixed within the device 100 at a negative gauge pressure within the cavity 112. The pump 150 can then be shut off, thereby maintaining a negative gauge pressure within the device 100, for example.

At 1112, for example, for an indication of the therapeutic fluid gauge pressure, a sensor 130, eg, a pressure sensor located within the cavity 112, may sense the fluid pressure within the cavity 112. The processor module 140 may receive a signal from the sensor 130, for example, an electrical signal proportional to the gauge pressure of the treatment fluid. The received sensor signal can be compared with a control circuit to a predetermined set point value, for example a pseudo-recommended negative gauge pressure of a therapeutic fluid for treatment of an eye disease. In case the received sensor signal exceeds the predetermined gauge pressure set point value, the speed of the fan 153 can be increased at 1111, thereby increasing the volumetric fluid attraction in the mixing chamber 146, for example. And the treatment fluid can be re-detected at 1113. Pump 150 may continue to produce volumetric fluid attraction until, for example, the gauge pressure sensed within cavity 112 reaches a predetermined gauge pressure set point value. In an example, the gauge pressure in device 100 may exceed the pseudo-recommended negative gauge pressure, for example, the negative gauge pressure in cavity 112 may be less than the pseudo-recommended negative gauge pressure.

At 1114, the spout 144 can be adjusted. Adjustment of the spout 144 allows air to be drawn into the device 100 from the surrounding environment, thereby reducing the negative gauge pressure in the cavity 112, for example. In an example, the spout 144 may be adjusted by a predetermined method, so that, for example, the negative gauge pressure in the cavity 112 is within a certain error band of the negative gauge pressure set point value, for example pseudo- It can be reduced with the recommended negative gauge pressure.

At 1116, the valve of fluid regulator 120C may be closed. Closing the fluid regulator 120C may stop the medical fluid from flowing out of the fluid source 170. In an example, the valve may be closed at a predetermined rate, for example a selected rate to prevent a change in the concentration of the treatment fluid.

At 1118, sensor 130 may sense an indication of the treatment fluid within cavity 112, for example for deviations from a specific setpoint value. In an example, an indicator of the concentration of the medical fluid in the treatment fluid can be detected by a gas sensor, and with the control circuit, a pseudo-recommended concentration setpoint level and a tolerance range (or Error band). In an example, an indication of negative gauge pressure in the treatment fluid can be detected by the pressure sensor, and with the control circuit, a pseudo-recommended negative gauge pressure setpoint level and a tolerance around the setpoint level, for example approximately It can be compared to a range (or error band). When the sensed indicator decreases outside the tolerance range, the method 1100 can be restarted, eg, at 1104, and adjusts the sensed indicator to a value within the tolerance range accordingly.

12 depicts an exemplary method 1200 for controlling the level of water vapor (ie, humidity) within the cavity 112, eg, the level of humidity entrained in the treatment fluid. Maintaining the physician-recommended humidity level can enhance the effect of the therapeutic fluid in contact with the eye. However, condensate may form in the cavity 112 due to, for example, the accumulation of sweat. Control of the humidity level can hinder the formation of condensate while improving treatment efficiency and patient comfort during use of the device 100.

At 1202, sensor 130, eg, a humidity sensor located within cavity 112, may detect an indication of a humidity level in the treatment fluid.

At 1204, an indicator of the humidity level within the cavity 112 may be compared to a setpoint value, thereby determining, for example, whether the humidity level has been achieved. In an example, the processor module 140 may receive a signal from the sensor 130, for example an electrical signal proportional to a humidity level indicator in the treatment fluid. The received sensor signal can be compared with a control circuit to a predetermined set point value, for example a specific humidity level for treatment of an eye disease.

At 1205, the humidity level in the treatment fluid can be adjusted. If the received sensor signal is less than the humidity level set point value, the valve of the fluid regulator 120 can be opened, and thus water vapor in the mixing chamber 146 that can be used, for example, for mixing into the treatment fluid. The concentration of can be increased and the treatment fluid can be re-detected at 904 and compared to the setpoint value. The valve of the fluid regulator 120 may continue to open until the received sensor signal reaches a predetermined humidity level set point value. If the received sensor signal is greater than the humidity level set point value, a filter 158, for example a dehumidifying filter, may be exposed to the treatment fluid, for example at least a portion of the treatment fluid in the passageway 157, and Accordingly, excess water vapor can be collected and removed.

At 1206, water vapor, such as water vapor entrained in the treatment fluid, and accumulated condensate may be collected from the apparatus 100. For example, by operating the fan 153 to circulate the treatment fluid within the device 100, the treatment fluid flowing through the passageway 157 may be exposed to at least a portion of the dehumidification filter, for example It may be brought into contact with it, and thus, for example, water vapor may be collected from the device 100. The amount of treatment fluid exposed to the dehumidification filter may be controlled by a sliding valve, for example by a sliding valve that covers the dehumidification filter and communicates with the control circuit of the processing module 140. The control circuit may adjust the slide valve and thus adjust the surface area of the dehumidifying filter exposed to the treatment fluid, for example, and thus control the rate at which water vapor is extracted from the treatment fluid.

For example, condensate accumulated in the cavity 112 may be collected, for example, with the absorbent gasket 160. For absorption by the absorbent core 162, the condensate may be in contact with the absorbent core 162, for example, the first surface 163 of the absorbent core 162. The absorbed condensate may be distributed through the absorbent core 162 by, for example, an osmotic phenomenon, and may be retained within the absorbent core 162.

At 1208, the collected water vapor may be removed from the device 100. In an example, a dehumidifying filter, for example a dehumidifying filter saturated with water vapor, may be replaced in the pump 150, for example with a dry dehumidifying filter, thereby removing water vapor from the device 100. In an example, the dehumidification filter may be exposed to the surrounding atmosphere, so that for example water vapor may evaporate from the desiccant. In an example, the dehumidification filter may comprise a heater element, for example integrated into the dehumidification filter, thereby increasing the temperature of the dehumidification filter to cause the collected water vapor to evaporate into the surrounding atmosphere, for example.

Accumulated condensate, for example condensate retained within the absorbent core 162 may be removed from the apparatus 100. In an example, the condensate may move through the core cover 166, for example from the inner surface 167 to the outer surface 168, and may be evaporated from the outer surface 168, for example For example, condensate can be removed from the device 100. In an example, a negative gauge pressure may be created within the lumen of the suction tube 169, thereby attracting condensate retained within the suction tube 162, for example, to the suction tube 169. A condensate pump comprising a pump with a negative gauge pressure separated from the device 100, for example a standalone vacuum pump capable of communicating with the control circuit of the processor module 140, and a pump contained within the device 100, For example, it may be produced by the pump 150.

At 1210, sensor 130 may sense an indicator of the treatment fluid within cavity 112, for example for deviations from a specific setpoint value. In an example, an indication of humidity in the treatment fluid can be detected by a humidity sensor and, with a control circuit, a pseudo-recommended humidity set point level and a tolerance range (or error band) about, for example, about the set point level. Can be compared to When the detected indicator decreases outside the tolerance range, the method 1200 may be restarted, for example at 1202, and adjusts the sensed indicator to a value within the tolerance range accordingly.

Various comments and examples

The foregoing detailed description includes reference to the accompanying drawings that form part of the detailed description. The drawings, by way of example, show specific embodiments in which the present invention may be practiced. These examples are also referred to herein as “examples”. Some examples may include elements other than those shown or described. However, the inventors also contemplate that only such elements are provided with examples shown or described. In addition, the inventors also contemplate such elements (or one or more aspects thereof) shown or described in connection with a particular example (or one or more aspects thereof), or in connection with another example (or one or more aspects thereof) shown or described herein. Also contemplated is an example using any combination or substitution of.

In the event of inconsistent usage between this document and any document incorporated by reference, the usage in this document takes precedence.

In this document, the indefinite article ("a" or "an") in order to include one or more than one, regardless of the use of "at least one" or "one or more" in any other case or as usual in the patent document. Is used. In this document, unless otherwise indicated, the term "or" is used to refer to non-exclusive, or "A or B" is "includes A but does not include B", "B includes A is It is used to include "not including", and "including A and B". In this document, terms such as "comprising" and "herein" are used as general English equivalents of the respective terms "including" and "in that respect". In addition, in the following claims, “comprising” and “comprising” are open, ie, a system, device, article, composition, formulation, or process comprising elements other than those listed after that term in the claim It will still be included within the scope of that claim. In addition, in the following claims, terms such as "first", "second", and "third" are used only as indications and are not intended to impose numerical requirements on the subject.

The method examples described herein may be at least partially mechanically or computer-implemented. Some examples may include computer-readable media or machine-readable media, encoded with instructions that can be operated to configure an electronic device for performing a method as described in the examples above. Implementations of such a method may include code, such as microcode, assembly language code, high-level language code, or the like. Such code may include computer readable instructions for implementing various methods. Code can form part of a computer program product. Also, in an example, the code may be tangible stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, for example during execution or at other times. Examples of such tangible computer-readable media include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks or digital video disks), magnetic cassettes, memory cards or sticks, random access Memory (RAM), read-only memory (ROM), and others.

The foregoing description is illustrative and is not intended to be limiting. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments may be used, for example by those skilled in the art who have reviewed the above description. In the abstract, to ensure that the reader quickly characterizes the technical disclosure, 37 C.F.R. It is provided in accordance with § 1.72(b). It will be understood that the submitted abstract will not be used to interpret or limit the scope or meaning of the claims. Further, in the foregoing detailed description, various features may be combined together to streamline the disclosure. This should not be construed as implying that the disclosed features, which are not claimed, are essential in any claim. Rather, the subject matter of the present invention may not include all features of a particular disclosed embodiment. Accordingly, it will be understood that the following claims are hereby incorporated into the detailed description as examples or embodiments, each claim standing on its own as a separate embodiment, and that such embodiments may be combined with each other in various combinations or permutations. The scope of the present invention should be determined with reference to the appended claims, along with the full range of equivalents given by the appended claims.

Claims (15)

A device for controlling the humidity level of the fluid in the cavity above the anterior surface of the patient's eye:
An enclosure sized and shaped to form a cavity over the anterior surface of the patient's eye, the cavity configured to contain a fluid in contact with the patient's eye; And
A humidity sensor in communication with the cavity and configured to sense an indication of a humidity level in the cavity, the apparatus comprising: a humidity sensor in communication with a processor circuit configured to control a humidity level of a fluid in the cavity. The method of claim 1,
An apparatus comprising a pressure source in fluid communication with the cavity and configured to change the humidity level within the cavity. The method of claim 2,
Wherein the pressure source comprises a filter configured to change humidity. The method of claim 3,
And a slide valve configured to regulate fluid flow to the filter to adjust the humidity level of the fluid in the cavity. The method of claim 4,
An actuator attached to the slide valve, the actuator in communication with the processor circuit. The method of claim 1,
Wherein the sheath comprises an absorbent gasket for isolating the cavity from the surrounding environment and controlling condensation within the cavity. The method of claim 6,
Wherein the absorbent gasket comprises an absorbent core configured to absorb condensate from the sheath cavity and a core cover configured to encapsulate the absorbent core and control a speed of movement of the condensate through the absorbent gasket. The method of claim 7,
Wherein the core cover is made of a porous material selected to control the speed of movement of the condensate through the absorbent gasket. The method of claim 7,
Wherein the absorbent core comprises a first surface and the core cover is configured to substantially encapsulate the first surface. The method of claim 7,
Wherein the core cover includes a receiving hole, the receiving hole extending through the core cover to arrange the absorbent core to communicate with the surrounding environment. The method of claim 7,
The apparatus, wherein the suction gasket comprises a suction tube. The method of claim 11,
The suction tube is attached to the core cover, and the lumen of the suction tube communicates with the absorbent core. The method of claim 11,
Wherein the suction gasket comprises a condensate pump attached to the suction tube. The method of claim 13,
The condensate pump is configured to generate negative pressure to draw condensate in the cavity through the absorbent core to remove condensate from the cavity. The method of claim 11,
Wherein the suction tube is attached to a pressure source.

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